Janssen的呼吸道合胞病毒RSV疫苗被FDA授予突破性疗法指定

2019-09-05 不详 MedSci原创

Janssen宣布其预防性疫苗用于预防60岁或以上成人呼吸道合胞病毒(RSV)介导的下呼吸道疾病,喜获美国食品和药物管理局(FDA)的突破性疗法指定。

Janssen宣布其预防性疫苗用于预防60岁或以上成人呼吸道合胞病毒(RSV)介导的下呼吸道疾病,喜获美国食品和药物管理局(FDA)的突破性疗法指定。

该指定是基于Janssen的预防性RSV高级疫苗的临床数据,"与临床可用护理标准相比,该疫苗显示出实质性改善"。

研究预防性疫苗目前正处于IIb期概念证明研究中,以研究在65岁及以上成人中RSV疫苗的安全性和有效性。

Janssen疫苗和预防全球治疗领域负责人表示:"由于目前没有预防性疫苗或有效的抗病毒治疗,RSV仍然是高危人群,尤其是老年人疾病的重要原因。"

RSV是一种非常普遍且具有传染性的呼吸道感染,是导致支气管炎和肺炎的主要原因,每年在全世界范围内影响超过6400万人。由于RSV的症状很难与流感或其他呼吸道感染区分开来,许多感染RSV的人可能无法正确诊断

原始出处:


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    2019-09-08 sakura-117_51758708

    好厉害

    0

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    2019-09-07 zhmscau
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    2019-09-07 feather81
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